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Tissue Adhesive For Internal Use

Page Type
Product Code
Definition
Approximation of tissue layers where subcutaneous dead space exists between the tissue planes in abdominoplasty.
Physical State
A surgical adhesive based on a polyurethane pre-polymer. In its pre-polymerized form, this is a viscous liquid. The primary component of the adhesive is created by reacting trimethylolpropane (TMP) with lysine di-isocyanate ethyl ester (LDI).
Technical Method
The liquid is applied drop-wise to the tissue surfaces to be adhered, and then the tissue surfaces are approximated for several minutes to allow the moisture in the tissue to initiate the curing process. The applicator is a hand-held, disposable device that stores 5 ml of adhesive for delivery in drops onto planar surfaces of tissue. When exposure to water, the product reacts with amine and hydroxyl groups on biological tissue and with itself to produce a polymerized network.
Target Area
Abdominoplasty tissue flaps
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
PMA
Device Classification
Class 3
Regulation Number
878.4010
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4010 Tissue adhesive

§ 878.4010 Tissue adhesive.

(a) Tissue adhesive for the topical approximation of skin - (1) Identification. A tissue adhesive for the topical approximation of skin is a device intended for topical closure of surgical incisions, including laparoscopic incisions, and simple traumatic lacerations that have easily approximated skin edges. Tissue adhesives for the topical approximation of skin may be used in conjunction with, but not in place of, deep dermal stitches.

(2) Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: “Tissue Adhesive for the Topical Approximation of Skin.” See § 878.1(e) of this chapter for the availability of this guidance document.

(b) Tissue adhesive for non-topical use - (1) Identification. A tissue adhesive for non-topical use, including adhesives intended for use in the embolization of brain arteriovenous malformation or for use in ophthalmic surgery, is a device used for adhesion of internal tissues and vessels.

(2) Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 878.3 of this chapter.

[73 FR 31033, May 30, 2008]

Tissue Adhesive For Internal Use

Page Type
Product Code
Definition
Approximation of tissue layers where subcutaneous dead space exists between the tissue planes in abdominoplasty.
Physical State
A surgical adhesive based on a polyurethane pre-polymer. In its pre-polymerized form, this is a viscous liquid. The primary component of the adhesive is created by reacting trimethylolpropane (TMP) with lysine di-isocyanate ethyl ester (LDI).
Technical Method
The liquid is applied drop-wise to the tissue surfaces to be adhered, and then the tissue surfaces are approximated for several minutes to allow the moisture in the tissue to initiate the curing process. The applicator is a hand-held, disposable device that stores 5 ml of adhesive for delivery in drops onto planar surfaces of tissue. When exposure to water, the product reacts with amine and hydroxyl groups on biological tissue and with itself to produce a polymerized network.
Target Area
Abdominoplasty tissue flaps
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
PMA
Device Classification
Class 3
Regulation Number
878.4010
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4010 Tissue adhesive

§ 878.4010 Tissue adhesive.

(a) Tissue adhesive for the topical approximation of skin - (1) Identification. A tissue adhesive for the topical approximation of skin is a device intended for topical closure of surgical incisions, including laparoscopic incisions, and simple traumatic lacerations that have easily approximated skin edges. Tissue adhesives for the topical approximation of skin may be used in conjunction with, but not in place of, deep dermal stitches.

(2) Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: “Tissue Adhesive for the Topical Approximation of Skin.” See § 878.1(e) of this chapter for the availability of this guidance document.

(b) Tissue adhesive for non-topical use - (1) Identification. A tissue adhesive for non-topical use, including adhesives intended for use in the embolization of brain arteriovenous malformation or for use in ophthalmic surgery, is a device used for adhesion of internal tissues and vessels.

(2) Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 878.3 of this chapter.

[73 FR 31033, May 30, 2008]